FDA Mandates "Boxed Warning" For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: Yahoo! Finance
caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies. According to the agency, these blood cancer treatments may pose a risk of secondary cancers The health regulator has required related updates to other label sections, such as warnings and precautions, postmarketing experience, patient counseling information, and medication guides. The agency said patients and clinical trial participants receiving treatment with these products should be monitored lifelong for secondary malignancies and notify the manufacturer in the event of a new malignancy. In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies The agency said it's weighing “the need for regulatory action” in response to clinical testing and safety monitoring reports tied to commercial use. In Januar
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- Strategic Advisory for Leading Therapeutics Innovation Inc. (SALTI) Announces Launch to Set New Standard in Life Sciences Commercialization Management Consulting [Yahoo! Finance]Yahoo! Finance
BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 4/25/24 - Form 10-Q
- 4/25/24 - Form 8-K
- 4/22/24 - Form DEFA14A
- BMY's page on the SEC website